The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and bioequivalence (BE) studies to support ...

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...

The Food and Drug Administration's (FDA) drug review arm has proposed withdrawing approval for Amgen Inc.’s AMGN Tavneos (avacopan), citing concerns over data integrity, lack of proven effectiveness, ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...

Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...

Data integrity is an ongoing concern across all R&D organizations, no matter what part of the research lifecycle they’re navigating. These concerns extend beyond the potential for delayed timelines or ...

DUBLIN--(BUSINESS WIRE)--The "Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance" training has been added to ResearchAndMarkets.com's offering.

SUNNYVALE, Calif.--(BUSINESS WIRE)--DvSum, a leader in data intelligence management, is pleased to announce its partnership with Booz Allen Hamilton and the U.S. Food and Drug Administration (FDA) to ...

The warning letter, issued on March 30 following a September 2025 inspection, says the company’s manufacturing practices have failed to comply with good manufacturing norms ...